3rd European Conference on Copper in Plant Protection 15 th -16 th November in Berlin, Germany

Transcription

1 3rd European Conference on Copper in Plant Protection 15 th -16 th November in Berlin, Germany

2 GERMAN FEDERAL INSTITUTE FOR RISK ASSESSMENT Human health risk assessment of copper compounds across different regulatory areas European Conference on Copper 2018 Dr. Jens Schubert

3 BfR tasks - overview Biological safety Food safety Healthy animals Healthy food Chemical safety Healthy people Product safety Quelle: Fotolia, C Taylor Experimental toxicology Risk communication page 2

4 Chemical safety Healthy animals Healthy food Chemical safety Healthy people page 3

5 Plant Protection Products page 4

6 Plant Protection Products Background levels Food of plant origin: nuts (13-37 mg/kg), cocoa powder (38 mg/kg), oilseeds (12-17 mg/kg), pulses (6-8 mg/kg), wheat germs (17 mg/kg), wheat bran (13 mg/kg) Food of animal origin: liver (calf's liver: 55 mg/kg), kidney (4-8 mg/kg), prawns (11 mg/kg), cheese (13 mg/kg) Drinking water limit: 2 mg/l page 5

7 Plant Protection Products Derivation of reference values essential human intake: daily intake via drinking water and food: maximum intake via drinking water and food: dose not affecting the homeostatic mechanism: dose without harmful effects after copper supplementation in humans: toxic effects after repeated ingestion: 1 mg/day 2 mg/day 10 mg/day 10 mg/day 10 mg/day 30 mg/day page 6

8 Plant Protection Products Derivation of reference values ADI (EFSA 2008, EFSA 2018): 0.15 mg Cu / kg bw per day, based on human data, supported by 90-day, rat, oral (NOAEL: 16 mg/kg bw/day) 10 mg per day / 60 kg 0.17 mg Cu / kg bw per day 10 mg per day / 70 kg 0.14 mg Cu / kg bw per day EFSA Journal 2018;16(1):5152: it was noted that an upper limit for copper as a nutrient had been established in an opinion of the EU Scientific Committee for Food (SCF, 2003), based on a NOAEL of 10 mg Cu/day value but adding an uncertainty factor of 2, resulting in a proposed tolerable upper intake level of 5 mg Cu/day for adults (corresponding to half of the ADI currently set in the pesticides area). This approach was considered by the Peer Review in 2008 as inadequate for setting an ADI in the area of pesticides (France, 2007a,b). [ ] During the current Peer Review, the experts have confirmed the previous assessment, and no changes in the ADI are proposed. page 7

9 Plant Protection Products Derivation of reference values Acceptable Daily Intake (ADI): 0.15 mg Cu/kg bw/day EFSA Scientific Report (2008) 187, 1-101, doi: /j.efsa r EFSA Journal 2018;16(1):5152, 1-25, doi: /j.efsa Tolerable Upper Intake (TUI): children 1-3 years: 1 mg/day children 4-6 years: 2 mg/day children 7-10 years: 3 mg/day adolescents years: 4 mg/day adults: 5 mg/day Scientific Committee for Food (SCF) der EFSA, 2006: Tolerable upper intake levels for Vitamins and Minerals, page 8

10 Plant Protection Products Derivation of reference values Acceptable Operator Exposure Level (AOEL): 0.08 mg/kg bw EFSA Journal 2018;16(1):5152, 1-25, doi: /j.efsa operators: risk assessment acceptable without PPE workers: risk assessment acceptable with PPE bystanders and residents: risk assessment acceptable for low application rates... no consideration of other exposure pathways for operators, workers, bystanders and residents page 9

11 Biocidal Products Copper compounds approved as active substances: PT 2 Disinfectants and algaecides not intended for direct application to humans or animals PT 8 Wood preservatives PT 21 Antifouling products Biocidal products authorized in Germany: PT 8 Wood preservatives page 10

12 Food safety Food safety Healthy animals Healthy food Healthy people page 11

13 Feed additives Recommendations for daily supply 1 : cattle's, dairy cows: 10 mg/kg feed dry matter piglets 6 mg/kg feed dry matter porker 4 5 mg/kg feed dry matter breeding sows 8 10 mg/kg feed dry matter horses 10 mg/kg feed dry matter poultry 6 8 mg/kg feed dry matter 1 Society for nutrition physiology (Gesellschaft für Ernährungsphysiologie (GfE)) page 12

14 Feed additives page 13

15 Feed additives Authorised copper compounds as additives in feedingstuff Copper(II) diacetate, monohydrate Copper(II) carbonate, dihydroxy monohydrate Copper(II) chloride, dihydrate Copper(II) oxide Copper(II) sulphate, pentahydrate Copper(II) chelate of amino acids hydrate Copper(II) chelate of protein hydrolysates Maximum content of Cu in mg/kg of complete feed piglets (up to 4 weeks/ 5 th 8 th week): 150/100 mg/kg feed bovines before the start of rumination: 15 mg/kg feed other bovines: 30 mg/kg feed ovines: 15 mg/kg feed caprines: 35 mg/kg feed other species: 25 mg/kg feed page 14

16 Food supplements Annex II: Substances which may be used in the manufacture of food supplements Copper carbonate Copper citrate Copper gluconate Copper sulphate Copper lysine complex No EU-wide regulation for maximum levels in food supplements available Proposal BfR: adults maximum 1 mg Cu per daily dose (not suitable for children/adolescents) page 15

17 Product safety Healthy animals Healthy food Quelle: Fotolia, C Taylor Product safety Healthy people page 16

18 Cosmetics and Food Contact Materials copper compounds can be used for cosmetic purposes as colorants: (29H,31H-Phthalocyaninato(2-)-N29, N30, N31, N32 copper), (Polychloro copper phthalocyanine), (Copper) Annex I: Union list of authorised substances: Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin, iron and allow of copper, tin and iron Copper iodide, Copper bromide Annex II: Restrictions on materials and articles: Copper = 5 mg/kg food or food simulant page 17

19 Biological safety Biological safety Healthy animals Healthy food Healthy people page 18

20 Antibiotic resistance Question: Does copper play a role in the development of antibiotic resistance in bacteria and does this impact human or animal health? According to scientific literature a correlation between resistance to copper and resistance to antibiotics can not be excluded General conclusions to a possible antibiotic co-selection from the use of copper according to the good agricultural practice are currently not possible With regard to the question in view of BfR, no reliable risk assessment for human or animal health is currently possible based on the current scientific and technical knowledge page 19

21 Risk communication Healthy animals Healthy food Risk communication Healthy people page 20

22 Risk communication page 21

23 Conclusion Natural Background Supplementation Supplementation Quelle: planet-wissen.de Plant protection Food of plant origin Food of animal origin Food supplement Drinking water Biocides page 22

24 Conclusion Copper intake in mg/kg bw/day ADI TUI 3 years TUI 13 years TUI 17 years years 5-13 years years LOQ = value LOQ = zero page 23

25 Conclusion Consideration of all exposure routes e.g. via drinking water Due to various exposure routes, risk assessment should use monitoring data Alignment of the different regulatory areas necessary Copper intake should be further monitored! page 24

26 GERMAN FEDERAL INSTITUTE FOR RISK ASSESSMENT Thank you for your attention Dr. Jens Schubert German Federal Institute for Risk Assessment Max-Dohrn-Str Berlin, GERMANY Phone Fax